The need to address the continued disproportionate burden of disease in Sub-Saharan Africa, resulting from epidemics of HIV/AIDS, tuberculosis, and malaria, as well as increasing rates of such chronic diseases as diabetes, heart disease, and cancer, has dramatically expanded the role for medical research with human participants in the region, and with it the need for thorough and effective ethics review. Lusophone countries fall far behind the rest of Africa, with only one fully operational REC in Portuguese-speaking countries: the Mozambique National Bioethics Committee. The increasing number of research proposals in Mozambique has become an issue of concern for the National Bioethics Committee, to the point that it recently established guidelines for the development of regional and institutional research ethics committees (RECs) to handle the growing influx of proposals. Despite advances in the national infrastructure for the review of human participant research, only a small number of professionals have the knowledge and skills necessary to apply standardized ethical concepts to the research proposals submitted for review. As such, there is significant need for capacity building in the review of human participant research as well as increasing the numbers of qualified investigators who can apply international standards in ethics to their study protocols and who can provide leadership for Mozambique in sustaining a culture for the ethical conduct of research.
The specific aims of this study are to 1) create a cadre of Mozambican leaders in biomedical research with in- depth knowledge and practical skills in both research design and the responsible conduct of research (RCR), through tailored masters programs for early-career investigators and mentored research in research ethics at VUMC; 2) enhance the knowledge and practical skills of Mozambican REC members and biomedical science educators in research ethics and RCR; and 3) create, evaluate, and distribute curricular materials on research ethics and responsible conduct of research tailored to Portuguese speakers in Sub-Saharan Africa. A team of experienced research ethics educators from VUMC, UEM, and the National Bioethics Committee seeks to create the Collaborative Research Ethics Education (Formaao Colaborativa na Etca em Pesquisa, FoCEP) program. We propose a series of interrelated educational activities aimed at building capacity for ethical design, review and conduct of biomedical research in Mozambique. These activities will 1) train Mozambican researchers and research administrators in the design, review, and conduct of biomedical research that meets the highest ethical and scientific standards; 2) strengthen the development and institutionalization of a system for ethical review in Mozambique's biomedical research institutions, 3) enhance the knowledge of standards and approaches to research ethics among biomedical science educators in Mozambique's academic research institutions, and 4) create an annual course and comprehensive curricular materials on research integrity and research with human participants for African investigators and trainees.
The VU-Collaborative Research Ethics Education (Forma?ao Colaborativa na Etica em Pesquisa, FoCEP) program will nurture a new generation of global health researchers from Mozambique in the ethical review of human participant research and the responsible conduct of research (RCR). This program will also strengthen the development and institutionalization of a system for ethical review of human research protocols in Mozambique's biomedical research institutions and newly developed Research Ethics Committees (REC). The present proposal has been developed in response to focused and carefully considered requests from the leadership of UEM and the Mozambican National Bioethics Committee for VUMC's assistance in developing national capacity for ethical review of human studies protocols and teaching research ethics to biomedical and public health investigators.
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